Revenue Growth
Product revenues of $10.1 million in Q1 2026, an increase of approximately 17% year-over-year from $8.6 million in Q1 2025.
Unit Volume Momentum
Ameluz unit volumes increased ~16% YoY from ~25,000 tubes in Q1 2025 to ~29,000 tubes in Q1 2026, supporting revenue growth and reflecting stronger commercial adoption.
Gross Margin Expansion
Gross margin expanded to approximately 80% in Q1 2026 versus ~62% in Q1 2025 (an ~18 percentage point improvement), driven by the new earnout cost structure and a ~40% reduction in cost of revenues (from $3.1M to $1.8M).
Near-Breakeven Operating Cash Flow
Cash used in operating activities was near zero at $70,000 in Q1 2026 versus $4.1 million used in Q1 2025, signaling dramatic improvement and supporting the company's path to cash flow breakeven this year.
Improved Adjusted EBITDA and Margin
Adjusted EBITDA improved to -$3.6 million from -$4.4 million in the prior year (an improvement of ~$0.8M). Adjusted EBITDA margin improved to -35% from -51% (16 percentage point improvement).
Installed Base and Lamp Placements
Shipped ~32 RhodoLED lamps in Q1 2026, growing the installed base to approximately 773 lamps across 709 dermatology offices, supporting future recurring product sales.
Regulatory and Clinical Progress — sBCC
FDA accepted the supplemental NDA for Ameluz PDT for superficial basal cell carcinoma with a PDUFA target action date of September 28, 2026—potential to be the first PDT drug approved to treat a cancer in the U.S., creating a significant commercial opportunity.
Positive AK Phase III Results and Planned sNDA
Positive, statistically significant Phase III results for actinic keratosis on extremities, neck and trunk; database lock for required PK study completed and plan to file supplemental NDA in Q3 2026 to expand the AK label up to 240 cm² treatment field.
Encouraging Acne Phase II Data
Phase II acne study showed a 58% reduction in inflammatory lesions with Ameluz versus 37% with vehicle (3-hour incubation); 86% patient satisfaction indicating strong potential; plan to discuss Phase III design with FDA in H2 2026.
Corporate and Strategic Wins
Completed strategic transaction giving full U.S. rights/control of Ameluz and RhodoLED (closed Oct 2025, NDA/IND transferred Dec 2025) and regained NASDAQ compliance on May 6, 2026; earnout structure (12%/15%) replaced prior 25%–35% transfer pricing.